Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement

Canadian Radiostereometric Analysis Network

Status

Enrolling

Conditions

Osteo Arthritis Knee

Treatments

Device: Attune Cementless

Study type

Interventional

Funder types

Other

Identifiers

NCT06189872

ATTUNE2024

Details and patient eligibility

About

This is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.

Full description

All patients will undergo post-operative radiostereometric analysis (RSA) and computed tomography (CT) to quantify and characterize the in vivo migration pattern of the Attune AFFIXIUM Cementless Tibial Baseplate and the Attune POROCOAT Cementless Femoral Component up to 24 months. Patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. Peri-operative adverse events and other clinical complications will be captured as encountered.

Enrollment

30 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
Patients aged 21 years or older
Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
Patients willing and able to comply with follow-up requirements and self-evaluations
Ability to give informed consent

Exclusion criteria

Active or prior infection of ipsilateral extremity
Medical condition precluding major surgery
Inflammatory arthropathy
Posterior cruciate ligament (PCL) deficiency
Major coronal plane deformity
Conditions that are cautioned against or contraindicated, as listed in the product monograph and/or instruction for use
Bone defects requiring augments, cones and/or stemmed implants